http://www.raredr.com/news/mercks-mm-hold
FDA Puts Clinical Hold on Merck's Multiple Myeloma Trials Following Increased Deaths

James Radke

Merck announced that the U.S. Food and Drug Administration (FDA) has placed a complete clinical hold on 2 clinical trials testing Keytruda (pembrolizumab) in combination with pomalidomide or lenalidomide to treat multiple myeloma. The FDA is also placing a partial hold on a 3rd multiple myeloma trial in which one treatment group in the study was receiving pembrolizumab plus lenalidomide
 
The decision was taken after a review of the data found more deaths in multiple myeloma patients receiving pembrolizumab in combination with pomalidomide or lenalidomide than in the control groups in 2 clinical trials.
 
This clinical hold does not apply to other clinical trials involving Keytruda which is being tested in a number of cancer populations. This hold only applies to multiple myeloma patients receiving pembrolizumab in combination with pomalidomide or lenalidomide.
 
The following studies have been placed on full clinical hold:
 
The following study has been placed on partial clinical hold:
 
Per a news release: “Patient safety is Merck’s primary concern, and we are grateful to the study investigators and patients involved in these studies for their commitment to this important research,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Merck’s development program for Kyetruda, spanning more than 30 different tumor types, has one priority: helping patients suffering from cancer.”
 
Keytruda (pembrolizumab) is approved for a variety of rare and common cancers, including:  
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